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2014-11-21
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Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability
Notices
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D09002ee1bdc37d79
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry'' dated December 2014. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance).
79 FR 69496
https://www.govinfo.gov/app/details/FR-2014-11-21/2014-27521
2014-27521
fr21no14-75
4164-01-P
Docket No. FDA 1999-D-3528 (Formerly Docket No. 1999D-5046)
https://www.govinfo.gov/app/details/FR-2014-11-21/2014-27521
https://www.govinfo.gov/content/pkg/FR-2014-11-21/html/2014-27521.htm
https://www.govinfo.gov/content/pkg/FR-2014-11-21/pdf/2014-27521.pdf
2 p.
69496
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79 FR 69496
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-27521
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA 1999-D-3528 (Formerly Docket No. 1999D-5046)
4164-01-P
2014-27521
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry'' dated December 2014. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance).
Submit either electronic or written comments on Agency guidances at any time.
Jonathan McKnight, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance for Industry and Staff:
Changes to an Approved ApplicationBiological ProductsHuman Blood and Blood Components Intended for Transfusion or for Further Manufacture
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 225
Office of the Federal Register, National Archives and Records Administration
2014-11-21
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-11-21
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0097-6326
0042-1219
0364-1406
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000582072
f:fr21no14
https://www.govinfo.gov/app/details/FR-2014-11-21
https://www.govinfo.gov/content/pkg/FR-2014-11-21/pdf/FR-2014-11-21.pdf
https://www.govinfo.gov/content/pkg/FR-2014-11-21/xml/FR-2014-11-21.xml
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